Status:
COMPLETED
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Anemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving s...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- chronic kidney disease, not requiring dialysis;
- receiving darbepoetin alfa maintenance therapy for \>=8 weeks before screening, and during screening/baseline period.
Exclusion
- overt gastrointestinal bleeding within 8 weeks before screening, or during screening/baseline period;
- transfusion of red blood cells within 8 weeks before screening, or during screening/baseline period;
- active malignant disease;
- previous treatment with Mircera.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00442702
Start Date
September 1 2007
End Date
August 1 2010
Last Update
December 19 2011
Active Locations (91)
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1
Granada Hills, California, United States, 91344
2
Lauderdale Lakes, Florida, United States, 33313
3
Augusta, Georgia, United States, 30309
4
Mineola, New York, United States, 11501